Comparison of Penetrating Keratoplasty and Deep Lamellar Keratoplasty With the Big Bubble Technique for Keratoconus

Phase 3

• Conditions: Keratoconus

• Registration Number: NCT00371202
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

it is a randomized clinical trial to compare deep lamellar keratoplasty (DLK) Using big bubble technique and Penetrating Keratoplasty (PK) in patients with keratoconus

Detailed Description

In this randomized clinical trial 50 keratoconic eyes of 50 patients randomly assigned in two groups: 25 patients underwent DLK with the big bubble technique and the other 25 patients underwent PK with the standard technique using hessburg - Barron trephine. One surgeon performed all operations using a 16 bites separate 10-0 nylon sutures. We used A-scan ultrasonic biometry for measuring vitreous length (VL) before surgery. If VL≥15.50mm, a trephine 0.25mm larger than recipient and if VL was \<15.50mm, a trephine 0.50 mm larger than recipient were considered. Selective suture removal was started 3 months after operation. quality of vision endothelial cell changes and correlation between refractive outcome and VL in relation to donor-recipient disparity, were measured and analyzed in both PK and DLK 15 mos postoperatively.

Study Timeline

• Study Start: 2006-07
• Study Completion: 2006-08
• Study First Submitted: 2006-08-31
• Study First Submitted QC: 2006-08-31
• Study First Posted: 2006-09-01
• Status Verified: 2007-01
• Last Update Submitted: 2007-01-12
• Last Update Posted: 2007-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• moderate to severe keratoconus
• contact lens intolerance
• low visual acuity due to anterior stromal scar
• age between 15 to 50 years

Exclusion Criteria

• posterior stromal scar with descemets membrane involvement
• history of hydrops
• fuchs endothelial dystrophy
• glaucoma
• cataract
• history of intraocular surgery
• history of vernal keratoconjunctivitis
• intraoperative complications
• reoperation (resuturing- regraft)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Uncorrected visual acuity (UCVA), best corrected visual acuity(bcva), refractive astigmatism, endothelial cell density, mean cell area, polymegathism (CV), Contrast sensitivity, Root-mean-square (RMS) Wavefront error, Pearson correlation factor between

Trial Locations

Locations (1)

Bahram Einollhi, MD; 🇮🇷 Tehran, Iran, Islamic Republic of